If the bioavailability (i.e., the rate and extent of availability) of an active ingredient common to two distinct pharmaceutical products is nearly the same, whenever the drugs are given in the same molar dose and through the same route of administration (e.g., oral route), the two drug products are considered as being bioequivalent
. It is expected that two bioequivalent
drug formulations have comparable in vivo performances and, therefore, share a common optimized dose regimen and an identical clinical efficacy and safety profile (5,6).
It also provides important capabilities to FEMSA Comercio in the operation of standalone beauty store retail banners, pharmaceutical distribution to third-party clients, and the production of generic and bioequivalent
Serbia's Pharmaceutical Group STADA began selling drug, a bioequivalent
to Viagra, in Germany.
drug formulations have the same bioavailability; that is, the same rate and extent of absorption.
"People mistake bioequivalent
as identical to the brands but scientifically, bioequivalent
means similar but not the same.
Two different algal oil capsule supplements and an algal oil-fortified food represent bioequivalent
and safe sources of DHA.
Hecoria is an AB-rated generic therapeutic bioequivalent
to Prograf (tacrolimus capsules) approved by the FDA for the prevention of organ rejection in patients receiving liver or kidney transplants.
The Food and Drug Administration approved the marketing of generic topiramate for seizure disorders in April, and maintains that generic formulations of any drug must be bioequivalent
to the brand formulation.
Results of the study indicate that the MetControl Metformin chewing gum and traditional Metformin tablets are bioequivalent
in respect of both the rate and the extent of systemic absorption such that MetControl and Metformin tablets are therapeutically equivalent and therefore interchangeable.
A recent position paper from the American Academy of Neurology (AAN) states that generic anti-seizure medications may not be bioequivalent
to their brand name versions.
Under data exclusivity, a controversial rule first imposed in 1987, for a period of about eight years after approval of a new drug, a country cannot accept an application for a generic bioequivalent
to a brand-name drug even if the patent is expired or is otherwise not a problem, because that is called "unfair" use of the knowledge that the brand-name drug worked in the first place.